Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response (IZAR-2)
A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Moonlake Clinical Trial Helpdesk
- Phone Number: +41 41 510 8022
- Email: ClinicalTrials@moonlaketx.com
Study Locations
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Pazardzhik, Bulgaria, 4400
- Recruiting
- Clinical Site
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Pleven, Bulgaria, 5800
- Recruiting
- Clinical Site
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Plovdiv, Bulgaria, 4004
- Recruiting
- Clinical Site
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Plovdiv, Bulgaria, 4002
- Recruiting
- Clinical Site
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Plovdiv, Bulgaria, 4003
- Recruiting
- Clinical Site
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Plovdiv, Bulgaria, 4000
- Recruiting
- Clinical Site
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Plovdiv, Bulgaria, 4001
- Recruiting
- Clinical Site
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Rousse, Bulgaria, 7000
- Recruiting
- Clinical Site
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Sofia, Bulgaria, 1606
- Recruiting
- Clinical Site
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Sofia, Bulgaria, 1784
- Completed
- Clinical Site
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Stara Zagora, Bulgaria, 6003
- Recruiting
- Clinical Site
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Calgary, Canada, T2N 4L7
- Recruiting
- Clinical Site
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Trois-Rivières, Canada, G9A 3X2
- Recruiting
- Clinical Site
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Waterloo, Canada, N2J 1C4
- Recruiting
- Clinical Site
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Winnipeg, Canada, R3A IM3
- Recruiting
- Clinical Site
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Ontario
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Toronto, Ontario, Canada, M5S1B2
- Recruiting
- Clinical Site
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Brno, Czechia, 63800
- Recruiting
- Clinical Site
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Ostrava, Czechia, 70200
- Recruiting
- Clinical Site
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Studénka, Czechia, 742 13
- Recruiting
- Clinical Site
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Zlín, Czechia, 760 01
- Recruiting
- Clinical Site
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Caluire-et-Cuire, France, 69300
- Recruiting
- Clinical Site
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Montpellier, France, 34295
- Recruiting
- Clinical Site
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Narbonne, France, 11100
- Completed
- Clinical Site
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Nice, France, 06001
- Recruiting
- Clinical Site
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Rouen, France, 76031
- Recruiting
- Clinical Site
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Tours, France, 37170
- Recruiting
- Clinical Site
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Tbilisi, Georgia, 0102
- Recruiting
- Clinical Site
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Tbilisi, Georgia, 0112
- Recruiting
- Clinical Site
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Tbilisi, Georgia, 0141
- Recruiting
- Clinical Site
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Tbilisi, Georgia, 0159
- Recruiting
- Clinical Site
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Tbilisi, Georgia, 0179
- Recruiting
- Clinical Site
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Tbilisi, Georgia, 0180
- Recruiting
- Clinical Site
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Berlin, Germany, 12161
- Recruiting
- Clinical Site
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Berlin, Germany, 12203
- Recruiting
- Clinical Site
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Berlin, Germany, 13125
- Recruiting
- Clinical Site
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Dresden, Germany, 01067
- Recruiting
- Clinical Site
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Erlangen, Germany, 91054
- Recruiting
- Clinical Site
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Hamburg, Germany, 20095
- Recruiting
- Clinical Site
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Herne, Germany, 44649
- Recruiting
- Clinical Site
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Munich, Germany, 80639
- Recruiting
- Clinical Site
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Munich, Germany, 81667
- Recruiting
- Clinical Site
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München, Germany, 80336
- Recruiting
- Clinical Site
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Budapest, Hungary, 1027
- Recruiting
- Clinical Site
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Budapest, Hungary, 1036
- Recruiting
- Clinical Site
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Budapest, Hungary, 1036
- Completed
- Clinical Site
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Debrecen, Hungary, H-4032
- Recruiting
- Clinical Site
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Gyula, Hungary, 5700
- Recruiting
- Clinical Site
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Hódmezővásárhely, Hungary, 6800
- Recruiting
- Clinical Site
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Nyíregyháza, Hungary, 4400
- Recruiting
- Clinical Site
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Szolnok, Hungary, 5000
- Recruiting
- Clinical Site
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Székesfehérvár, Hungary, 8000
- Recruiting
- Clinical Site
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Veszprém, Hungary, 8200
- Recruiting
- Clinical Site
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Bialystok, Poland, 15707
- Recruiting
- Clinical Site
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Bydgoszcz, Poland, 85-065
- Recruiting
- Clinical Site
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Częstochowa, Poland, 42-202
- Completed
- Clinical Site
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Elblag, Poland, 82-300
- Recruiting
- Clinical Site
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Gdynia, Poland, 81-384
- Recruiting
- Clinical Site
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Krakow, Poland, 30-002
- Recruiting
- Clinical Site
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Krakow, Poland, 30-149
- Recruiting
- Clinical Site
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Krakow, Poland, 31-501
- Recruiting
- Clinical Site
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Lodz, Poland, 91-363
- Recruiting
- Clinical Site
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Nadarzyn, Poland, 05-830
- Recruiting
- Clinical Site
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Poznan, Poland, 60-324
- Recruiting
- Clinical Site
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Poznan, Poland, 60-446
- Recruiting
- Clinical Site
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Poznan, Poland, 60-693
- Recruiting
- Clinical Site
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Poznan, Poland, 61-397
- Recruiting
- Clinical Site
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Sochaczew, Poland, 96-500
- Recruiting
- Clinical Site
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Swidnica, Poland, 58100
- Recruiting
- Clinical Site
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Warsaw, Poland, 02-665
- Recruiting
- Clinical Site
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Warsaw, Poland, 03-291
- Recruiting
- Clinical Site
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Warsaw, Poland, 00-874
- Recruiting
- Clinical Site
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Warsaw, Poland, 02-118
- Recruiting
- Clinical Site
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Warsaw, Poland, 02-677
- Recruiting
- Clinical Site
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Warsaw, Poland, 04-305
- Recruiting
- Clinical Site
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Wołomin, Poland, 05-200
- Recruiting
- Clinical Site
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Wroclaw, Poland, 51-685
- Recruiting
- Clinical Site
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Wroclaw, Poland, 53-673
- Recruiting
- Clinical Site
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A Coruña, Spain, 15006
- Recruiting
- Clinical Site
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Bilbao, Spain, 48013
- Recruiting
- Clinical Site
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Castellon, Spain, 12004
- Recruiting
- Clinical Site
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Madrid, Spain, 28003
- Recruiting
- Clinical Site
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Málaga, Spain, 29009
- Recruiting
- Clinical Site
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Sabadell, Spain, 08208
- Recruiting
- Clinical Site
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Santiago de Compostela, Spain, 15702
- Recruiting
- Clinical Site
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Santiago de Compostela, Spain, 15706
- Recruiting
- Clinical Site
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Seville, Spain, 41009
- Recruiting
- Clinical Site
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Seville, Spain, 41010
- Recruiting
- Clinical Site
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Seville, Spain, 41013
- Recruiting
- Clinical Site
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Valencia, Spain, 46010
- Recruiting
- Clinical Site
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Barnet, United Kingdom, EN5 3DJ
- Recruiting
- Clinical Site
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Leeds, United Kingdom, LS7 4SA
- Recruiting
- Clinical Site
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Essex
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Westcliff-on-Sea, Essex, United Kingdom, SS0
- Recruiting
- Clinical Site
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Arizona
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Avondale, Arizona, United States, 85392
- Recruiting
- Clinical Site
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Chandler, Arizona, United States, 85225
- Completed
- Clinical Site
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Flagstaff, Arizona, United States, 86001
- Completed
- Clinical Site
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Mesa, Arizona, United States, 85210
- Recruiting
- Clinical Site
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Phoenix, Arizona, United States, 85032
- Recruiting
- Clinical Site
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Scottsdale, Arizona, United States, 85260
- Recruiting
- Clinical Site
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Tucson, Arizona, United States, 85748
- Recruiting
- Clinical Site
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- Recruiting
- Clinical Site
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California
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La Jolla, California, United States, 92037
- Recruiting
- Clinical Site
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Pomona, California, United States, 91767
- Recruiting
- Clinical Site
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San Diego, California, United States, 92108
- Recruiting
- Clinical Site
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Santa Monica, California, United States, 90404
- Recruiting
- Clinical Site
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Thousand Oaks, California, United States, 91360
- Recruiting
- Clinical Site
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Upland, California, United States, 91786
- Recruiting
- Clinical Site
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Florida
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Avon Park, Florida, United States, 33825
- Recruiting
- Clinical Site
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Clearwater, Florida, United States, 33765
- Recruiting
- Clinical Site
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Hialeah, Florida, United States, 33016
- Recruiting
- Clinical Site
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Miami Gardens, Florida, United States, 33014
- Recruiting
- Clinical Site
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Tampa, Florida, United States, 33607
- Recruiting
- Clinical Site
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Zephyrhills, Florida, United States, 33542
- Recruiting
- Clinical Site
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Georgia
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Gainesville, Georgia, United States, 30501
- Recruiting
- Clinical Site
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Illinois
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Springfield, Illinois, United States, 62702
- Recruiting
- Clinical Site
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Louisiana
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Lake Charles, Louisiana, United States, 70605
- Recruiting
- Clinical Site
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Maryland
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Baltimore, Maryland, United States, 21224-6821
- Recruiting
- Clinical Site
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Michigan
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Grand Blanc, Michigan, United States, 48439-2451
- Recruiting
- Clinical Site
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New York
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Brooklyn, New York, United States, 11201
- Recruiting
- Clinical Site
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Rochester, New York, United States, 14642
- Recruiting
- Clinical Site
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North Carolina
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Charlotte, North Carolina, United States, 28262
- Recruiting
- Clinical Site
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Leland, North Carolina, United States, 28451
- Recruiting
- Clinical Site
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Ohio
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Middleburg Heights, Ohio, United States, 44130
- Recruiting
- Clinical Site
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Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- Clinical Site
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Recruiting
- Clinical Site
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Tennessee
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Jackson, Tennessee, United States, 38305
- Recruiting
- Clinical Site
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Memphis, Tennessee, United States, 38119
- Recruiting
- Clinical Site
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Murfreesboro, Tennessee, United States, 37128
- Completed
- Clinical Site
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Texas
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Allen, Texas, United States, 75013
- Completed
- Clinical Site
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Austin, Texas, United States, 78745
- Recruiting
- Clinical Site
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Baytown, Texas, United States, 77521
- Recruiting
- Clinical Site
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Colleyville, Texas, United States, 76034
- Recruiting
- Clinical Site
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Houston, Texas, United States, 77089
- Completed
- Clinical Site
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Lubbock, Texas, United States, 79424
- Recruiting
- Clinical Site
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Plano, Texas, United States, 75024
- Recruiting
- Clinical Site
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Washington
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Seattle, Washington, United States, 98122
- Recruiting
- Clinical Site
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West Virginia
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Beckley, West Virginia, United States, 25801
- Recruiting
- Clinical Site
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must be ≥18 years of age .
- Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
- Participants have active disease (defined by a 68 tender joint count [TJC68] of ≥3 and a 66 swollen joint count [SJC66] of ≥3).
- Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
- Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
- Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.
Exclusion Criteria:
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
- Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
- Participants with a diagnosis of inflammatory bowel disease.
- Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
- Participants who have an established diagnosis of arthritis mutilans.
- Previous exposure to sonelokimab.
- Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: sonelokimab dose 1 with an induction regimen
Subjects randomized to this arm will receive sonelokimab dose 1 subcutaneously (SC) as an induction regimen of 4 doses , followed by sonelokimab SC every 4 weeks (Q4W) maintenance dosing starting at Week 8.
|
Sonelokimab
|
|
Experimental: sonelokimab dose 2 with an induction regimen
Subjects randomized to this arm will receive sonelokimab dose 2 SC as an induction regimen of 4 doses, followed by sonelokimab SC Q4W maintenance dosing starting at Week 8.
|
Sonelokimab
|
|
Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo SC
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Placebo
|
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Active Comparator: risankizumab
Subjects randomized to this arm will receive risankizumab SC
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Active comparator
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Time Frame: Week 16 compared to placebo
|
Proportion of participants achieving ACR50
|
Week 16 compared to placebo
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20)
Time Frame: Week 16 compared to placebo
|
Proportion of participants achieving ACR20
|
Week 16 compared to placebo
|
|
Response rate of participants achieving Minimal Disease Activity (MDA)
Time Frame: Week 16 compared to placebo
|
Proportion of participants achieving MDA
|
Week 16 compared to placebo
|
|
Health Assessment Questionnaire- Disability Index (HAQ-DI)
Time Frame: Week 16 compared to placebo
|
Change in HAQ-DI from baseline
|
Week 16 compared to placebo
|
|
Psoriasis Area and Severity Index (PASI90)
Time Frame: Week 16 compared to placebo
|
Proportion of participants achieving a decrease of ≥90% in the PASI90 response at Week 16 in the subgroup of participants with psoriasis (PsO) involving ≥3% body surface area at baseline
|
Week 16 compared to placebo
|
|
Short- form-36 (SF-36) Physical Component Summary (PCS)
Time Frame: Week 16 compared to placebo
|
Change from Baseline in SF-36 PCS at Week 16
|
Week 16 compared to placebo
|
|
Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50)
Time Frame: Week 16 compared to risankzumab
|
Proportion of participants achieving ACR50
|
Week 16 compared to risankzumab
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- M1095-PSA-302
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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